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NCT01062854 Clinical Trial

Effects of Earplugs on Sleep and Sleep Apnea

Sleep Disordered Breathing Clinical Trial

Official title:
Effects of Earplugs on Sleep and Sleep Apnea

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01062854
Other study ID # HUM00023548
Secondary ID
Status Completed
Phase N/A
First received February 3, 2010
Last updated December 3, 2016
Start date November 2008
Est. completion date August 2012

Study information
Verified date December 2016
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The main goal of this study is to assess whether use of earplugs has any effect on sleep, sleep apnea, and daytime sleepiness in individuals who snore.

Recruitment information / eligibility
Status Completed
Enrollment 407
Est. completion date August 2012
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adults, ages 18 or older

- Scheduled at the University of Michigan Sleep Disorders Center for a diagnostic polysomnogram to evaluate for sleep-disordered breathing

Exclusion Criteria:

- Medical, psychiatric or other conditions that would interfere with interpretation of the results of the sleep studies or the subject's ability to complete the Stanford Sleepiness Scale

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

Intervention

Other:
• Soft earplugs are worn during sleep study
Subjects are asked to wear earplugs when possible for 3-5 nights prior to their baseline sleep study. On the night of their sleep study they are randomized to either "wears earplugs" or "no earplugs" groups.

Locations
Country Name City State
United States University of Michigan Sleep Disorders Center Ann Arbor Michigan

Sponsors (1)
Lead Sponsor Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

References & Publications (1)

Chirakalwasan N, Ruzicka DL, Burns JW, Chervin RD. Do snoring sounds arouse the snorer? Sleep. 2013 Apr 1;36(4):565-71. doi: 10.5665/sleep.2546. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Sleep measures (rates of apneas and hypopneas, oxygen desaturation, arousals, sleep stages, respiratory cycle-related EEG changes [RCREC]) up to 2 years after the sleep study No
Secondary Subjective sleepiness measures (Stanford Sleepiness Scale) on awakening after the sleep study No
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